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, 7 (11), e11317

Living With Inflammatory Bowel Disease: Protocol for a Longitudinal Study of Factors Associated With Symptom Exacerbations

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Living With Inflammatory Bowel Disease: Protocol for a Longitudinal Study of Factors Associated With Symptom Exacerbations

Kelcie Witges et al. JMIR Res Protoc.

Abstract

Background: There has been limited longitudinal research that has comprehensively evaluated possible factors in the exacerbation of inflammatory bowel disease (IBD) symptoms with or without associated inflammation. Evolving Web-based technologies facilitate frequent monitoring of patients' experiences and allow a fine-grained assessment of disease course.

Objective: We aimed to prospectively identify factors associated with symptom exacerbation and inflammation in IBD including psychological functioning, diet, health behaviors, and medication adherence.

Methods: Between June 2015 and May 2017, we enrolled adults with IBD, recruited from multiple sources, who had been symptomatically active at least once within the prior 2 years. They completed a Web-based survey every 2 weeks for 1 year and submitted a stool sample at baseline, 26 weeks, and 52 weeks. Any participant reporting a symptom exacerbation was matched to a control within the cohort, based on disease type, sex, age, and time of enrollment; both were sent a supplemental survey and stool collection kit. Biweekly surveys included validated measures of the disease course, psychological functioning, health comorbidities, and medication use. Intestinal inflammation was identified through fecal calprotectin (positive level >250 μg/g stool).

Results: There were 155 participants enrolled with confirmed IBD, 66.5% (103/155) with Crohn disease and 33.5% (52/155) with ulcerative colitis, of whom 98.7% (153/155) completed the study. Over the 1-year period, 47.7% (74/155) participants experienced a symptom exacerbation. The results of analyses on risk factors for symptom exacerbations are pending.

Conclusions: We recruited and retained a longitudinal IBD cohort that will allow the determination of risk factors for symptom exacerbation with and without inflammation. This will increase understanding of symptom exacerbations among persons with IBD.

International registered report identifier (irrid): RR1-10.2196/11317.

Keywords: Crohn disease; Web-based; diet; flare; inflammatory bowel disease; survey; ulcerative colitis.

Conflict of interest statement

Conflicts of Interest: CNB is supported in part by the Bingham Chair in Gastroenterology. He has served on advisory boards for AbbVie Canada, Ferring Canada, Janssen Canada, Shire Canada, Takeda Canada, Pfizer Canada, and Napo Pharmaceuticals. He has consulted with 4D Pharma and Mylan Pharmaceuticals. He has received educational grants from AbbVie Canada, Shire Canada, Takeda Canada, Janssen Canada, and Pfizer Canada and has been on the speakers’ panel for Ferring Canada and Shire Canada. LET has served on advisory boards for Takeda Canada, Janssen Canada, Pfizer Canada, and Mallinckrodt, USA. The other authors have no conflicts to report.

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